[5-29-2026] The Food and Drug Administration is advising consumers not to purchase or use Big Dick Energy!, a product promoted and sold for male sexual enhancement on various websites and possibly in some retail stores.

FDA laboratory analysis confirmed that Big Dick Energy! contains tadalafil not listed on the product label.

Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. FDA approval of Cialis is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief and body building and are often represented as being all natural. Consumers should exercise caution before purchasing these products.

FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.

For more information:

• Medication Health Fraud
• Tainted Sexual Enhancement Products
• Dietary Supplements